Intensive Blood Pressure Intervention in Stroke (IBIS) Trial

NCT03585595 | Withdrawn Phase 3 DMC

• 1 other identifier: 1109724
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators propose to conduct a multicenter randomized controlled trial to test the effect of a systolic blood pressure target of less than 120 mmHg (intensive treatment) compared to a target of less than 140 mmHg (standard treatment) on the risk of total recurrent stroke (ischemic and hemorrhagic) among patients with a recent ischemic stroke. The study findings will help in the development of clinical guidelines for blood pressure management among patients with ischemic stroke and will have an important global impact on reducing stroke-related morbidity and mortality.

Conditions

Ischemic Stroke

Keywords

Antihypertensive treatment

Outcome Measures

Primary Outcomes (1)

• Stroke event

  Stroke will be diagnosed based on clinical data, including symptoms and signs, computed tomography (CT), and/or magnetic resonance imaging (MRI) of the brain and large vessels.

  Up to four years of follow-up

Secondary Outcomes (6)

• Composite major CVD events

  Up to four years of follow-up

• Myocardial infarction (MI)

  Up to four years of follow-up

• Non-MI acute coronary syndrome

  Up to four years of follow-up

• Heart failure

  Up to four years of follow-up

• Dementia

  Up to four years of follow-up

Study Arms (2)

Intensive treatment group

EXPERIMENTAL

Systolic BP target \<120 mmHg for the intensive treatment group

Other: Blood pressure lowering strategy

Standard treatment group

ACTIVE COMPARATOR

Systolic BP \<140 mmHg for the standard treatment group

Other: Blood pressure lowering strategy

Interventions

Blood pressure lowering strategy OTHER

The proposed trial will test a treatment strategy of different systolic BP goals and not specific medications. It remains unclear whether a particular class of antihypertensive drug offers an advantage over others in secondary stroke prevention. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications. However, we will emphasize the use of drugs best demonstrated to be effective in lowering CVD in outcome trials and recommended in current clinical guidelines.

Intensive treatment group; Standard treatment group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥40 years
• A history of symptomatic, MRI/CT-confirmed ischemic stroke (3-12 months since last acute onset)
• Systolic BP ≥140 mmHg on 0 medication; 135-180 mmHg on 1 medication; 135-170 mmHg on up to 2 medications; 135-160 mmHg on up to 3 medications; or 135-150 mmHg on up to 4 medications

You may not qualify if:

• Documented symptomatic intracranial and/or extracranial stenosis (≥50%), or asymptomatic intracranial and/or extracranial stenosis (≥70%)
• Disabling stroke (modified Rankin score of ≥4)
• Previous intracranial hemorrhage from a non-traumatic cause
• Any symptoms of orthostatic hypotension during the standing BP measurement, or standing systolic BP \<110 mmHg
• Severe heart failure (NY Heart Association class III and IV) within the past six months or left ventricular ejection fraction (by any method) \<35%
• Any history of atrial fibrillation, ventricular aneurysm, or suspicion of cardioembolic pathology for stroke
• Other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)
• Dialysis, eGFR \<20 ml/min/1.73 m2, urine protein-to-creatinine ratio ≥1 g/g, or albumin-to-creatinine ratio ≥ 600 mg/g
• Planned or probable revascularization (any angioplasty or vascular surgery) within three months after screening
• A medical condition likely to limit survival to less than three years
• A cancer diagnosed and treated within the past two years that, in the judgment of clinical study staff, would compromise a participant's ability to comply with the protocol and complete the trial (except non-melanoma skin cancer, early-stage prostate cancer, or localized breast cancer)
• Any factors judged by the clinic team to be likely to limit adherence to the intervention
• Failure to obtain informed consent from a participant
• Currently participating in another intervention study
• Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control

Sponsors & Collaborators

• Tulane University: lead
• Beijing Tiantan Hospital: collaborator

Related Publications (2)

• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

  PMID: 36398903 DERIVED

• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

  PMID: 32905623 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jiang He, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

• Yilong Wang

  Tiantan Hospital, Beijing Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants and study physicians/nurses will not be masked to patient randomization assignments due to different BP targets between the two randomization groups. However, study personnel who collect clinical outcome data at the baseline and follow-up examinations will be masked to patient assignments. The members of the Outcome Adjudication Committee will also be masked to patient randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with a recent ischemic stroke will be randomized to an intensive treatment strategy (a systolic BP target of \<120 mmHg) or a standard treatment strategy (a systolic BP target of \<140 mmHg) for up to four years.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 13, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02